← Back to catalogue
GEM Microvascular Anastomotic COUPLER Sterilization Tray
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- GEM Microvascular Anastomotic COUPLER Sterilization Tray FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- A reusable, single tier sterilization tray, consisting of an anodized aluminum base and cover with instrument holder bars. The tray is designed to hold the Anastomotic Instrument, Vessel Measuring Gauge, and up to two Coupler Forceps for steam sterilization and storage between uses. FDA UDI
- Model / Reference
- GEM 2745 FDA UDI
- Description
- A reusable, single tier sterilization tray, consisting of an anodized aluminum base and cover with instrument holder bars. The tray is designed to hold the Anastomotic Instrument, Vessel Measuring Gauge, and up to two Coupler Forceps for steam sterilization and storage between uses. FDA UDI
Identifiers
- Catalog Number
- 519302003010 FDA UDI
- Primary DI / UDI-DI
- 00844735002829 FDA UDI
- 510(k) Number
- K071783 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Device sterilization/disinfection container, reusable
GEM Microvascular Anastomotic COUPLER Sterilization Tray by Synovis Micro Companies Alliance, Inc — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Device sterilization/disinfection container, reusable.
- SM - LIPO PANTY CHEVILLES COUPE TAILLE NOIR AVEC TROUS RECOUVERTS SUR MESURE — MEDICAL Z · Class I
- APTUS — Medartis Inc. · Class I
- APTUS — Medartis Inc. · Class II
- INSTRUMENTS TRAYS WITHOUT LID, 200x100x25MM — DAUD JEE MFG. CO · Class I
- Breastform Cover Right Size 03 (478/ 482) — Trulife · Class I
- NCB® Periprosthetic Plate System — Zimmer, Inc. · Class I
- NTOC cassette — NTOC medische techniek B.V · Class I
- MIRABOR-CA (12 BURS)- — Hager Worldwide, Inc. · Class I
Cleared under the same submission
K071783 also covers:
- GEM MICROTRAY — SYNOVIS MICRO COMPANIES ALLIANCE, INC
- GEM MICROTRAY — SYNOVIS MICRO COMPANIES ALLIANCE, INC
- GEM MICROTRAY — SYNOVIS MICRO COMPANIES ALLIANCE, INC
- GEM MICROTRAY — SYNOVIS MICRO COMPANIES ALLIANCE, INC
- GEM MICROTRAY — SYNOVIS MICRO COMPANIES ALLIANCE, INC
- GEM MICROTRAY MAX — SYNOVIS MICRO COMPANIES ALLIANCE, INC
- GEM MICROTRAY MAX — SYNOVIS MICRO COMPANIES ALLIANCE, INC
- GEM Microvascular Anastomotic COUPLER System — SYNOVIS MICRO COMPANIES ALLIANCE, INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Synovis Micro Companies Alliance, Inc
Sources (1)
- FDA UDI 08d4e8ac-a90b-4810-9ec6-b1f736946f24 37 fields · synced May 30, 2026